1、June 2012 Translation by DIN-Sprachendienst.English price group 9No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11
2、.060.15!$|vk“1898372www.din.deDDIN EN 1642Dentistry Medical devices for dentistry Dental implantsEnglish translation of DIN EN 1642:2012-06Zahnheilkunde Medizinprodukte fr die Zahnheilkunde DentalimplantateEnglische bersetzung von DIN EN 1642:2012-06Mdicine bucco-dentaire Dispositifs mdicaux pour la
3、 mdicine bucco-dentaire Implants dentairesTraduction anglaise de DIN EN 1642:2012-06SupersedesDIN EN 1642:2010-02www.beuth.deDocument comprises 13 pagesIn case of doubt, the German-language original shall be considered authoritative.06.12 DIN EN 1642:2012-06 2 A comma is used as the decimal marker.
4、Start of validity This standard takes effect on 1 June 2012. National foreword This standard includes safety requirements. This standard has been prepared by Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normena
5、usschuss Dental (Dentistry Standards Committee), Working Group NA 014 BR-01 SO Europische Normung. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. Amendments This standard differs from DIN EN 1642:2010-02 as follows: a) A
6、nnex ZA “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC” has been updated; b) the French title has been updated; c) Subclause 4.2.2 now includes a reference to EN ISO 10451 for the contents of the technical file. Previous editions DIN EN 1642: 19
7、96-10, 2004-09, 2010-02 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1642 October 2011 ICS 11.060.15 Supersedes EN 1642:2009English Version Dentistry - Medical devices for dentistry - Dental implants Mdicine bucco-dentaire - Dispositifs mdicaux pour la mdicine bucco-dentaire - Implants denta
8、ires Zahnheilkunde - Medizinprodukte fr die Zahnheilkunde - Dentalimplantate This European Standard was approved by CEN on 20 September 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a nat
9、ional standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A ve
10、rsion in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus,
11、 Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT
12、 EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1642:2011: EEN 1642:2011 (E) 2 Contents page Foreword 3Introduction
13、. 41 Scope 52 Normative references 53 Terms and definitions . 64 Requirements . 64.1 General 64.2 Design and properties . 64.2.1 Materials . 64.2.2 Contents of technical file 64.2.3 Biocompatibility . 64.2.4 Biophysical properties and modelling 64.3 Control of contamination 74.3.1 General 74.3.2 Den
14、tal implants supplied sterile . 74.3.3 Dental implants supplied non-sterile . 74.3.4 Dental implants which incorporate materials of animal origin . 74.4 Dental implants used in combination 74.5 Clinical investigation and evaluation. 74.6 Marking, labelling and information supplied by the manufacture
15、r 84.6.1 General 84.6.2 Symbols 84.6.3 Label 84.6.4 Instructions for use . 8Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 10Bibliography 11DIN EN 1642:2012-06 EN 1642:2011 (E) 3 Foreword This document (EN 1642:2011) has
16、been prepared by Technical Committee CEN/TC 55 “Dentistry”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2012, and conflicting national standards
17、shall be withdrawn at the latest by April 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 1642:2009.
18、 This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC. For relationship with EU Directive 93/42/EEC, see informative Annex ZA, which is an integral part of this d
19、ocument. The following changes were made: a) normative references: 1) addition of new relevant product standards, issued after 2004: EN 1641, EN ISO 11135-1, EN ISO 11137-1, EN ISO 11607-1, EN ISO 11607-2, EN ISO 14801, EN ISO 14971, EN ISO 22794, EN ISO 22803; 2) deletion of the following withdrawn
20、 standards: EN 550, EN 552, EN ISO 14727; b) 4.5 Clinical evaluation: clarification of requirement for a clinical evaluation; c) 4.6.4 Instructions for use: clarification of requirement that information may be provided in an electronic format; d) Annex ZA: actualisation of the annex. According to th
21、e CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia
22、, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. DIN EN 1642:2012-06 EN 1642:2011 (E) 4 Introduction There are three levels of European Standards dealing with medical devices used in dentistry. These ar
23、e as follows: Level 1: General requirements for medical devices; Level 2: Requirements for families of medical devices used in dentistry; Level 3: Specific requirements for types of medical devices used in dentistry. There are no level 1 standards written exclusively in respect of medical devices us
24、ed in dentistry. This European Standard is a level 2 standard and details requirements that apply to dental implants (for surgically implantable dental materials included within the definition of restorative materials see EN 1641). It is also indicated that there are additional requirements in the l
25、evel 3 standards. Where available, these are included as normative references. To cover all the requirements for a particular product, it is necessary to use a standard of the lowest available level. In the bibliography a reference for guidance on the classification of dental devices and accessories
26、 4 is given. DIN EN 1642:2012-06 EN 1642:2011 (E) 5 1 Scope This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This European Standard i
27、ncludes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated refere
28、nces, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 556-1, Sterilization of medical devices Requirements for medical devices to be designated “STERILE“ Part 1: Requirements for terminally sterilized medica
29、l devices EN 980, Symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer of medical devices EN 21942-1:1991, Dental vocabulary Part 1: General and clinical terms (ISO 1942-1:1989) EN 21942-2:1992, Dental vocabulary Part 2: Dental materials (ISO 1942-2:1
30、989) EN ISO 1942-5:1994, Dental vocabulary Part 5: Terms associated with testing (ISO 1942-5:1989) EN ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008) EN ISO 10451, Dental implant systems Contents of technical file (ISO 10451:2002) EN ISO 10993-
31、1, Biological evaluation of medical devices Part 1: Evaluation and testing (ISO 10993-1:2003) EN ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) EN
32、 ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials,
33、 sterile barrier systems and packaging systems (ISO 11607-1:2006) EN ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) EN ISO 14155-1, Clinical investigation of medical devices for human sub
34、jects Part 1: General requirements (ISO 14155-1:2003) EN ISO 14155-2, Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans (ISO 14155-2:2003) EN ISO 14801, Dentistry Implants Dynamic fatigue test for endosseous dental implants (ISO 14801:2007) EN ISO 1497
35、1, Medical devices Application of risk management to medical devices (ISO 14971:2007) EN ISO 22794, Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of technical file (ISO 22794:2007) DIN EN 1642:2012-06 EN 1642:2011 (E) 6 EN ISO 22803, Den
36、tistry Membrane materials for guided tissue regeneration in oral and maxillofacial surgery Contents of technical file (ISO 22803:2004) ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times 3 Terms and definitions For the purposes of this document,
37、the terms and definitions given in EN 21942-1:1991, EN 21942-2:1992, EN ISO 1942-5:1994 and the following apply. 3.1 dental implants device designed to be placed surgically within or on the mandibular or maxillary bone to provide resistance to displacement of a dental prosthesis or to provide orthod
38、ontic anchorage NOTE The term dental implant includes transendodontic implants. 4 Requirements 4.1 General 4.1.1 Dental implants shall comply with the requirements which are applicable to them bearing in mind the intended purpose of the implant concerned. Conformity with these requirements shall be
39、considered to be met by demonstrating compliance with the requirements of the following subclauses, if appropriate. 4.1.2 Risk management shall be carried out and documented. This shall include a risk analysis in accordance with EN ISO 14971. 4.2 Design and properties 4.2.1 Materials Dental implants
40、 shall be manufactured from materials selected with regard to the properties required for the intended purpose. 4.2.2 Contents of technical file The contents of the manufacturers technical file shall be in accordance with EN ISO 10451, EN ISO 22794 and EN ISO 22803, if applicable. 4.2.3 Biocompatibi
41、lity Dental implants shall be assessed for biocompatibility. Guidance on the selection of tests is given in EN ISO 7405 and EN ISO 10993-1. EN ISO 7405 includes usage tests specific to dental materials. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to repr
42、oduction. NOTE Further information is given in Annex I of Council Directive 67/548/EEC of 27 June 1967. 4.2.4 Biophysical properties and modelling Dental implants, other than those designed to provide orthodontic anchorage, shall be assessed for mechanical stability by fatigue testing according to E
43、N ISO 14801. NOTE The stability of dental implants designed to provide orthodontic anchorage shall be assessed by mechanical tests with regard to the properties required for the intended purpose. DIN EN 1642:2012-06 EN 1642:2011 (E) 7 4.3 Control of contamination 4.3.1 General 4.3.1.1 Dental implant
44、s shall be manufactured under such conditions so as to minimize microbial or other contamination. 4.3.1.2 The condition in which dental implants are supplied shall be clearly stated, i.e. sterile, non-sterile. 4.3.2 Dental implants supplied sterile 4.3.2.1 Dental implants supplied sterile shall comp
45、ly with EN 556-1. 4.3.2.2 Sterilization processes shall be validated and routinely controlled: a) If dental implants are to be sterilized by ethylene oxide, EN ISO 11135-1 shall apply; b) If dental implants are to be sterilized by irradiation, EN ISO 11137-1 shall apply. 4.3.2.3 Packaging systems fo
46、r dental implants supplied sterile shall be such that the implants remain sterile until the package is opened. Packaging systems for dental implants supplied sterile shall be in accordance with EN ISO 11607-1 and EN ISO 11607-2. 4.3.3 Dental implants supplied non-sterile 4.3.3.1 Packaging systems fo
47、r dental implants supplied non-sterile shall maintain the level of cleanliness of the implants during transport and storage. 4.3.3.2 If dental implants are to be sterilized immediately prior to use the method of sterilization shall be given. 4.3.4 Dental implants which incorporate materials of anima
48、l origin The tissues of animal origin shall be from an approved source and shall have undergone appropriate inactivation, conservation and test procedures. NOTE Further information is given in EN ISO 22442-1 5. 4.4 Dental implants used in combination Dental implants used in combination with prefabricated components and connecting systems other than any custom made superstructure such as a den
